VENTANA MMR RxDx Panel
FDA premarket approval P210001/S003 · decided 2022-06-10
Approval details
- PMA number
- P210001
- Supplement
- S003
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VENTANA MMR RxDx Panel
- Generic name
- Immunohistochemistry test, DNA mismatch repair (MMR) Protein assay
- Applicant
- Ventana Medical Systems, Inc. (Roche Tissue Diagnostics)
- Date received
- 2022-01-28
- Decision date
- 2022-06-10
- Days to decision
- 133 days
- Decision code
- APPR
- Product code
- QNH
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Tucson, AZ
- Statement
- Approval for the addition of two new contract manufacturers as approved suppliers for component parts.
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